Marijuana - Rescheduling

7/29/2019 Marijuana - Rescheduling

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DoesSAMbelieveinreschedulingmarijuana,toScheduleIIorIIIforexample,

sothatwecanstudythemedicinalbenefitsofmarijuana?

SAM wholeheartedly believes we need to fast-track the FDA process toextract non--smoked medications from the cannabis plant. SAM also believes thatin the meantime, before we have more cannabis--based FDA-approvedmedications, the FDA and the U.S. Department of Health and Human Services

should administer a program permitting the truly sick and dying to receive yet-to--be approved, non-psychoactive, non--smoked components of marijuana under aspecial research program. But rescheduling marijuana is neither necessary, nordesirable, for those actions to happen.

Rescheduling marijuana would do nothing to allow more cannabis--basedmedicines. Cocaine is Schedule II today and is not allowed in a widespread fashion.Rescheduling would simply be a symbolic victory for advocates who want to

legalize marijuana..

Part of the confusion over the actual significance of Schedule II status stemsfrom a misunderstanding of the interrelated, but distinct, functions of the CSA and

the Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, the FDA approvesspecific medical products produced by particular innovator (for brandedproducts) or generic manufacturers. For example, oxycodone, an opioid, is inSchedule II. Specific products, such as OxyContin (an extended-release form), arealso in Schedule II. Physicians prescribe a specific branded or generic product, in aparticular dose and dosage form. So, until the FDA approves a smoked marijuanaproduct, it cannot be prescribed or sold in dispensaries for medical use. And theFDA has been clear that smoked marijuana does not pass its rigorous approvalstandards.

Imagine for a moment that the medical marijuana advocates were instead

medical opium advocates and that various states passed laws decriminalizing (oraffirmatively authorizing and regulating) the cultivation and distribution of opiumplant material in other words, opium latex or poppy straw. Even though opiumlatex and poppy straw are each in Schedule II, there still would be a conflict amongsuch state laws and both the CSA and the FDCA. As a well--known drug reformadvocacy website states: If poppies are gown as sources for opiates, there is noquestion that it violates the CSA. 1 Furthermore, physicians would not beauthorized to prescribe, nor pharmacists to dispense, dried opium latex or poppystraw. 2 To be prescribed, a specific product containing opiates would have to passmuster in the FDA-approval process. The mere act of placing herbal marijuana inSchedule II would not make it available to patients or address the conflict between

state and federal law.


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Butwontreschedulingallowforresearchtobedone?

No. Rescheduling is not necessary to make marijuana products available forresearch. A committee of the California Medical Association recently called for therescheduling of marijuana so it can be tested and regulated. However, it is notnecessary for marijuana to be rescheduled for legitimate research to proceed.Schedule I status does not prevent a product from being tested and researched for

potential medical use. Schedule I research certainly does go forward. In a recentpharmaceutical company--sponsored human clinical study investigating a productderived from marijuana extracts, the DEA registered approximately 30 researchsites in the U.S. and also registered an importer to bring the product into the U.S.from the U.K., where it was manufactured. 3 And a quick search of the NationalInstitutes of Healths news reveals more than $14 million of current research onmarijuana and medicine is moving forward. Research is happening.

Whataboutobtainingmarijuanaforresearch?

Researcherswishingtoconductstudieswithherbal/wholeplantmarijuana

mayobtainitfromtheNationalInstitutesofHealth(orimportformulatedextracts)..

ResearcherswhoobtaingrantfundingfromaninstituteoftheNationalInstitutesof

Health(NIH),suchasNIDA,canobtainmarijuanafortheirstudy;researcherswho

areexternallyfundedmustundergotheequivalentofagrantreviewprocess

(reviewoftheirstudydesignbyanexpertcommitteeofthePublicHealthService)in

ordertoobtainsuchmarijuanaatcostfromNIDA.NIH(viatheUniversityof

MississippisNationalCenterforNaturalProductsResearch)hastheabilityto

producestandardizedmarijuanaofvaryingTHCpotencies.Itscultivationareaoffiveacreshasbeenadequatetosupplyallmarijuana-relatedstudiestodate.4In

1http://www.erowid.org/plants/poppy/poppy_law.shtml2 Both Laudanum and Paregoric (tinctures of opium) pre-existed the original Food and Drugs Act of 1906.

Recently, the FDA has taken enforcement action against these products as unapproved drugs that have

not undergone FDA trials to prove safety and efficacy, as well as for violations of Good Manufacturing

Practices. See, e.g., FDA, Warning Letter, Hi-Tech Pharmacal Co., Inc (June 28, 2010),http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219984.htm (Paregoric). See also,

FDA, Guidance for FDA Staff and Industry, Marketed Unapproved DrugsCompliance Policy Guide,

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070290.

pdf.3

GW Pharmaceuticals, Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070573.

pdf(press release); DOJ, DEA, Importer of Controlled Substances; Notice of Registration, 71 Fed. Reg.

64298 (Nov. 1, 2006).4 See DOJ, DEA, Lyle E. Craker; Denial of Application, 74 Fed. Reg. 2101, 2104 (Jan. 14, 2009).


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Whathasbeentheresultofmedicalmarijuanainvariousstatesondruguse

rates?

Anin-depthexaminationofmedicalmarijuanaanditsrelationshiptothe

explosioninuseanduserscamein2012fromfiveepidemiologicalresearchersatColumbiaUniversity.Usingresultsfromseverallargenationalsurveys,they

concludedthat:residentsofstateswithmedicalmarijuanalawshadhigheroddsor

marijuanauseandmarijuanaabuse/dependencethanresidentsofstateswithout

suchlaws.5

Stateswithmedicalmarijuanalawsalsoshowmuchhigheraveragemarijuana

usebyadolescents,andlowerperceptionsofriskfromuse,thannon-medicalpot

states.11Thiswouldseemtoindicatethatrelaxedcommunitynormsaboutdruguse

contributegreatlytoanincreasedprevalenceofuseandusers,asituationresulting

fromthespreadofanattitudethatifpotismedicineandissanctionedbythestate,thenitmustbesafetousebyanyone.

Medicalmarijuanashouldreallyonlybeaboutbringingrelieftothesickanddying,anditshouldbedoneinaresponsiblemannerthatformulatestheactive

componentsofthedruginanon-smokedformthatdeliversadefineddose.However,inmoststateswithmedicalmarijuanalaws,ithasprimarilybecomea

licenseforthestate-sanctioneduseofadrugbymostanyonewhodesiresit.

Developingmarijuana-basedmedicationsthroughtheFDAprocessismorelikelytoensurethatseriouslyillpatients,whoarebeingsupervisedbytheiractualtreating

physicians,haveaccesstosafeandreliableproducts.

5Cerda, M. et al. (2011). Medical marijuana laws in 50 states: investigating the relationship between state

legalization of medical marijuana and marijuana use, abuse and dependence.Drug and AlcoholDependence. Found at http://www.columbia.edu/~dsh2/pdf/MedicalMarijuana.pdf; Wall, M. et al (2011).

Adolescent Marijuana Use from 2002 to 2008: Higher in States with Medical Marijuana Laws, Cause Still

Unclear,Annals of epidemiology, Vol21 issue 9 Pages 714-716.

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Marijuana - Rescheduling